A battery of toxicological studies was conducted on a supercritical CO2 extract of the aerial parts of the Cannabis sativa plant, containing approximately 25% cannabinoids. No evidence of genotoxicity was found in a bacterial reverse mutation test (Ames), in an in vitro mammalian chromosomal aberration test, or in an in vivo mouse micronucleus study. A 14-day repeated oral dose-range finding study conducted in Wistar rats at 1000, 2000, and 4000 mg/kg bw/day resulted in effects where a NOAEL could not be concluded. Based on those results, a 90-day repeated dose oral toxicity study was performed in rats using doses of 100, 360, and 720 mg/kg bw/day, followed by a 28-day recovery period for two satellite groups. Significant decreases in body weight, body weight gain, and differences in various organ weights compared to controls were observed. At the end of the recovery period, many of the findings were trending toward normal; thus, the changes appeared to be reversible. The NOAEL for the hemp extract in Hsd.Han Wistar rats was considered to be 100 mg/kg bw/day for males and 360 mg/kg bw/day for females.
There is a current worldwide interest in developing novel sustainable nonanimal nutritional sources, and one such source is the green algae Chlamydomonas reinhardtii, the only green algae that has been studied as a model organism for many biological processes ranging from photosynthesis to flagellar movement. However, its potential as a safe nutritional source for use in various foods has not been thoroughly investigated. To assess the safety of C reinhardtii for use as a nutritional human food ingredient, in accordance with internationally accepted standards, the genotoxic potential and repeated-dose oral toxicity of the dried C reinhardtii (THN 6) algal biomass was investigated. The following studies were conducted: (1) a bacterial reverse mutation test, (2) an in vitro mammalian chromosomal aberration test, (3) an in vivo mammalian micronucleus test, and (4) a 28-day repeated-dose oral toxicity study in rats. No evidence of mutagenicity or genotoxic activity was observed in the first 3 tests under the applied test systems. In the 28-day study, male and female Hsd.Han Wistar rats were exposed to daily doses of 0, 1,000, 2,000, and 4,000 mg/kg bw by gavage. Following 28 days of continuous exposure, no mortality or treatment-related adverse effects were observed and no target organs were identified. Therefore, a no observed adverse effect level was concluded as 4,000 mg/kg bw/day, the highest dose tested.
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